Mr.
Robert Farrell reports
KALYTERA ANNOUNCES ISSUANCE OF SECOND PATENT COVERING THE USE OF CBD IN GRAFT VERSUS HOST DISEASE
The U.S. Patent and
Trademark Office (USPTO) has issued to Kalytera Therapeutics Inc. U.S. patent No. 9,956,182
with claims covering the use of cannabidiol (CBD) for the
prevention and treatment of acute and chronic forms of graft-versus-host
disease (GVHD). Kalytera has exclusive worldwide rights to
this issued patent through an exclusive licence agreement with MOR
Research Applications Ltd. of Israel.
GVHD is a multisystem disorder that is a life-threatening complication
commonly occurring after bone marrow transplant procedures. GVHD occurs
when the transplanted donor cells attack the patient's organs, including
the skin, gastrointestinal tract, liver, lungs and eyes. GVHD is
associated with acute and chronic illness, infections, disability,
reduced quality of life and death.
In November, 2017, Kalytera announced that it had received notice from
the USPTO that the application for this patent would be allowed. The
issuance of this patent by the USPTO is the final step in the patent
application process and provides patent coverage to Kalytera for the
use of CBD in the prevention and treatment of acute and chronic forms of
GVHD through May, 2034, under the exclusive licence agreement with Mor.
This is the second patent covering the use of CBD in GVHD that Kalytera
has received in the past three weeks. On April 19, 2018, Kalytera announced
that the USPTO had issued U.S. patent No. 9,889,100 B2 with claims
covering the use of CBD for the treatment of severe and refractory GVHD.
"We are delighted by the issuance of this second patent for CBD in the
treatment and prevention of GVHD," said Robert Farrell, president and
chief executive officer of Kalytera. "We now have very strong intellectual property
protection that will provide us with market exclusivity for the use of
CBD in GVHD through early 2034."
Mr. Farrell went on to state: "Our program for prevention of GVHD
is in phase 2 clinical testing, and, later this year, we will begin a
phase 3 pivotal registration study in the treatment of GVHD. With our
GVHD program advancing into the final phases of clinical testing, we
will now begin seeking regional partners for commercialization of this
product outside of North America. Such partnering agreements can provide
non-dilutive sources of funding through licensing, milestone and royalty
revenue opportunities."
The commercial opportunity for Kalytera's CBD product in the treatment
and prevention of GVHD is large. According to the January, 2018, market
forecast report by DelveInsight Perspective, the potential size of the
market for a successful product in the seven major jurisdictions (the
United States, Germany, France, Italy, Spain, the United Kingdom and Japan) is estimated to
be more than $408-million (U.S.) in 2018 and could grow to approximately
$1.3-billion (U.S.) by 2027.
Kalytera acquired its program in the prevention and treatment of GVHD in
February, 2017, through the acquisition of Talent Biotechs Ltd. of Israel. Under its agreement with the former Talent
Biotechs shareholders, Kalytera is obligated to make additional contingent
payments to the former Talent Biotechs shareholders upon the achievement of
certain milestones, including upon the issuance of patents by the USPTO.
Upon the earlier issuance of U.S. patent No. 9,889,100 B2 by the USPTO,
Kalytera became obligated to make a payment to the former Talent
Biotechs shareholders of 2,883,535 common shares and a cash payment of $2-million (U.S.). With the issuance of U.S. patent No. 9,956,182 by the USPTO,
Kalytera is now obligated to make an additional cash payment to the
former Talent Biotechs shareholders of $2-million (U.S.).
About Kalytera Therapeutics
Inc.
Kalytera is pioneering the
development of a next generation of cannabinoid therapeutics. Through
its proven leadership, drug development expertise and intellectual
property portfolio, Kalytera seeks to establish a leading position in
the development of novel cannabinoid medicines for a range of important
unmet medical needs, with an initial focus on graft-versus-host disease
and the treatment of acute and chronic pain.
We seek Safe Harbor.
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